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NCT02719574 · ClinicalTrials.gov registry record · Phase 1
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
A Phase 1 study, sponsored by Forma Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 336
- Enrollment target
NCT02719574: Completed Phase 1 study, sponsored by Forma Therapeutics.
NCT02719574 is a Phase 1 study that has completed, run by Forma Therapeutics. The registered enrollment target is 336 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (460% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02719574, a Phase 1 study, has completed, sponsored by Forma Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 336 participants
- Enrollment target
Study Summary
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 (olutasidenib) (single agent) and FT-2102 (olutasidenib) + azacitidine (combination agent) administered via one or more intermittent dosing schedules followed by a dose expansion part. The dose expansion part will enroll patients in up to 5 expansion cohorts, exploring single-agent FT-2102 (olutasidenib) activity as well as combination activity with azacitidine or cytarabine. Following the completion of the relevant Phase 1 cohorts, Phase 2 will begin enrollment. Patients will be enrolled across 8 different cohorts, examining the effect of FT-2102 (olutasidenib) (as a single agent) and FT-2102 (olutasidenib) + azacitidine (combination) on various AML/MDS disease states.
Primary Outcome
A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-t
Interventions
- DRUG Azacitidine
- DRUG Cytarabine
- DRUG FT-2102 (olutasidenib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2016-04-30 |
| Est. Completion | 2024-01-24 |
| Phase | Phase 1 |
What the finished NCT02719574 record still lists
NCT02719574 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (460% higher).
The record links to 0 conditions, and to 3 interventions - of which Azacitidine is the first listed.
NCT02719574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02719574 about?
NCT02719574 is a clinical study titled "Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation". This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 (olutasidenib) as a single agent or in combination with azacitidine or cytarabine. The Phase 1 stage of the study is split into 2 distinct parts: a dose escalation part, which will utilize an open-label design of FT-2102 ...
What is the current status of trial NCT02719574?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 336 participants. The study started on 2016-04-30. Estimated completion is 2024-01-24.
What interventions are being tested in trial NCT02719574?
The interventions under investigation include: Azacitidine (DRUG), Cytarabine (DRUG), FT-2102 (olutasidenib) (DRUG).
Who is sponsoring clinical trial NCT02719574?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02719574's enrollment target sits among peer trials
336 106th of 2000 higher than 1,893 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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